2021年度碱性磷酸酶测定试剂盒北京市监督抽验质量分析  

The quality analysis of Beijing alkaline phosphatase test reagent kit in 2021

作　　者：宋伟 朱晋升 彭絮 代蕾颖 Song Wei;Zhu Jinsheng;Peng Xu;Dai Leiying(Beijing Institute of Medical Device Testing(Bejing Center for Testing and Reasearch of Medical Biological Protective Equipment),Beijing 101111,China)

机构地区：[1]北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心),北京101111

出　　处：《首都食品与医药》2023年第23期101-104,共4页Capital Food Medicine

摘　　要：目的对碱性磷酸酶测定试剂盒进行监督抽验,评价产品的质量状况,并通过对不符合项原因分析,以期发现质量安全风险点。方法采用产品技术要求中的评价方法,对碱性磷酸酶测定试剂盒重复性、准确性项目进行检验,采用EP30-A及EP14-A3方法,对血清校准品(朗道)互换性进行评价。结果碱性磷酸酶测定试剂盒重复性100%符合要求,准确性71.4%符合要求;血清校准品(朗道)在9组参考测量程序与常规测量程序间都不具有互换性;在36组常规测量系统间,血清校准水平2(朗道)在34组常规测量系统间不具有互换性,血清校准水平3(朗道)在33组常规测量系统间不具有互换性。结论碱性磷酸酶测定试剂盒准确性还存在一定问题,使用不具有互换性的第三方校准品并直接用说明书提供的靶值进行校准时,测量临床血清样本可能存在偏倚。Objective To evaluate the quality status of alkaline phosphatase test kit by supervising sampling in Beijing,and find out the quality and safety risk points by analyzing the causes of non-conformities.Methods Using methods from product technical requirements to evaluate the repeatability and accuracy of the alkaline phosphatase test kits,and the commutability of the serum calibrators(RANDOX)were evaluated by EP30-A and EP14-A3 methods.Results The repeatability of alkaline phosphatase test kits were 100%in conformity with the requirements,and the accuracy were 71.4%;serum calibrators(RANDOX)were not commutable in 9 groups of reference measurement procedure and routine measurement procedures;there were 36 groups of routine measurement procedures,serum calibration level 2(RANDOX)were not commutable in 34 groups,Serum calibration level 3(RANDOX)were not commutable in 33 groups.Conclusion There were some problems with the accuracy of alkaline phosphatase assay kit.When using a third-party calibrator without commutability and directly calibrating systems with the target value provided in the instructions,the results of clinical serum samples may be biased.

关 键 词：碱性磷酸酶测定试剂盒 监督抽验 准确度 

分 类 号：R194[医药卫生—卫生事业管理]